TWICE-yearly lenacapavir injections have shown efficacy in preventing HIV infection, offering a promising alternative to daily oral preexposure prophylaxis (PrEP) for males and gender-diverse persons.
In a Phase III clinical trial involving 3,265 participants, the incidence of HIV infection among those receiving subcutaneous lenacapavir every 26 weeks was significantly lower than those taking daily emtricitabine–tenofovir disoproxil fumarate (F/TDF). The study, which included cisgender men, transgender women, transgender men, and nonbinary individuals, found 0.10 infections per 100 person-years in the lenacapavir group compared to 0.93 in the F/TDF group.
The trial demonstrated that lenacapavir is not only effective but also safe, with minimal injection-site reactions leading to discontinuation. The findings suggest a paradigm shift in PrEP strategies, particularly for patients seeking less frequent dosing.
Given the significant reduction in HIV risk and the convenience of biannual administration, lenacapavir could broaden access and adherence for at-risk populations.
Reference: Kelley CF et al. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. NEJM. 2024. doi: 10.1056/NEJMoa2411858.
